Autonomic Nervous System, Blood Pressure, Cardiomyopathy, Hypertrophic, Endothelium, Physical Exercise
Conditions
Brief summary
Hypertrophic cardiomyopathy is a genetic heart disease with symptoms that may include dyspnea and fatigue predominantly on exertion, with or without chest pain, palpitations, syncope/presyncope and sudden cardiac death, mostly in young individuals, often without symptoms. Due to the higher cardiovascular risk described for individuals with hypertrophic cardiomyopathy, it is extremely important to create non-pharmacological strategies that can minimize the evolution of cardiovascular risk factors found in this population. The objective of the study will be to evaluate the effect of an aerobic exercise session on the ratio between the low frequency (LF) and high frequency (HF) bands of heart rate variability, endothelial function through flow-mediated dilation and systolic and diastolic blood pressure during the 24-hour period in adult individuals with hypertrophic cardiomyopathy. The study design will be a randomized crossover clinical trial with individuals aged 18 to 59 years, of both sexes, randomized by lottery and divided into two groups: Exercise group and control group without exercise. An exercise stress test will be performed and on a new date the individuals will perform a supervised session of moderate-intensity aerobic exercise on a horizontal stationary bicycle for 50 minutes or will remain seated in an air-conditioned room for the same period of time. Subsequently, the procedures will be crossed. It is expected to find improvements in the parameters of endothelial function, autonomic modulation and 24-hour blood pressure in adult individuals with non-obstructive hypertrophic cardiomyopathy undergoing a session of aerobic physical exercise when compared to a control session without exercise.
Interventions
OTHERExercise
An aerobic exercise session on a recumbent exercise bike with a 5-minute warm-up period, followed by a 40-minute cool-down period and ending with a 5-minute cool-down at decreasing speed.
Sponsors
Instituto de Cardiologia do Rio Grande do Sul
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No
Inclusion criteria
* The study population will consist of individuals aged between 18 and 59 years with HCM diagnosed via ICFUC medical records.
Exclusion criteria
* Individuals with a history of exercise-induced arrhythmias, a history of aborted sudden death, and the presence of an implantable cardioverter defibrillator will be excluded from the sample. Those with LVOT obstruction at rest ≥50 mmHg on medical therapy, recent septal reduction therapy, pregnancy, class IV symptoms in the New York Heart Association (NYHA) functional classification78, hypotensive response to exercise (drop in systolic BP \>20 mmHg in relation to the resting value or during exercise) will also be excluded. Concomitantly, those with systolic dysfunction of left ventricular ejection fraction \<50%, myocardial infarction, or previous stroke will be excluded. Hypertensive patients, those with orthopedic limitations, or any physical or mental limitation that prevents them from performing physical exercises will also be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of autonomic system function | From enrollment to the end of treatment at 2 weeks | Ratio between the low frequency (LF) and high frequency (HF) bands of heart rate variability by electrocardiogram |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of endothelial function | From enrollment to the end of treatment at 2 weeks | Flow-mediated dilation (FMD) by high-resolution Doppler ultrasound images of the brachial artery. |
| Blood pressure assessment | From enrollment to the end of treatment at 2 weeks | Ambulatory Blood Pressure Monitoring |
Countries
Brazil
Outcome results
None listed